The FDA's War on Vaping Will Cost Millions of Lives

Friday, January 20, 2017

Rep. Tom Price (R-GA) is a controversial pick for Secretary of Health and Human Services. During his Senate confirmation hearings, Democrats were clearly concerned about Price’s well-known desire to repeal and replace the Affordable Care Act. For his part, however, Price testified that his focus is on “improving the health and well-being of Americans.” If that is the case, there’s one simple change he could make as head of Health and Human Services that has the potential to save millions of American lives: stop the Food and Drug Administration’s dangerously foolish war on vaping.

Electronic cigarettes are likely not risk-free, but they are clearly less harmful than traditional cigarettes.

Thanks to the efforts of public health advocates, tobacco usage has declined from its height of popularity in the 1950s and 60s when more than 40% of all American adults smoked, down to just about 15% today. However, in recent years the rate of decline has slowed and smoking is a particularly stubborn habit among certain groups of people, especially those who are low-income and have less education. Considering that smoking traditional tobacco cigarettes kills about half of those with the habit, smoking cessation is, understandably, a top priority for health officials.

Electronic cigarettes or vapes, which involve no combustion, are likely not risk-free in the long-term, but they are clearly less harmful than traditional cigarettes. According to a Britain’s Department of Health, the available e-cigarette brands are at least 95 percent less harmful than regular cigarettes. According to a study published last summer, these tobacco alternatives could even lead to a 21 percent decline in deaths from smoking-related diseases for people born after 1997—even after taking into account possible harms people might suffer from vaping who otherwise would not have smoked at all. Put simply, even given the risks associated with vaping, there is a net public health gain from their existence in the market. This is why CEI, along with a coalition of other groups dedicated to free markets and innovation have signed a coalition letter imploring Congress to step in and stop the FDA’s plan to destroy the vaping market.

Twisted Incentives

The FDA’s so-called “Deeming Rule” took effect on August 16, 2016 and requires vaping products to undergo a pre-approval process so onerous and expensive it will functionally eliminate most, if not all, of the electronic cigarettes currently on the market. Those that remain will almost certainly become much more expensive. The FDA estimates that each application will cost about $330,000 and that companies will need to file 20 applications per product in the first two years—putting the total per product cost at $6 million. Even this number is high enough that only the largest tobacco companies could afford filing applications (with no guarantee that they will be approved), but other observers, like the National Center for Public Policy Research, estimate that the per-application is much higher, possibly $1 million. Even FDA admits that 99 percent of products won’t even bother filing applications, but will simply disappear from the market, leaving those consumers who have successfully switched from traditional cigarettes with fewer options and putting them at risk of returning to their deadly habit.

Why would FDA, which is charged with promoting the introduction of products that aid in tobacco cessation, implement rules that even it admits will result in the elimination of such products? The short answer is: they are scared.

The free market, because it bypassed regulation, succeeded where government health agencies failed.

The FDA generally isn’t held responsible for the suffering and deaths that result from a medicine, product, or service that wasn’t available due to its slow and prohibitively expensive approval process. It is, however, blamed for products that cause harm 20 or 30 years down the line. So, they err on the side of caution. The problem with vaping is, the cat is out of the bag.

Vaping burst onto the market during the last decade, a new technology that evolved rapidly with thousands of producers of devices and juices responding to consumer demand and bypassing regulatory approval. As a result of this vibrancy and customizability, electronic cigarettes—unlike the FDA-approved “big pharma” inhalers that preceded them—actually became popular. And that’s, perhaps, what scares FDA the most: the free market, because it bypassed regulation, succeeded where government health agencies failed. By responding to consumer demand, the market actually created a tobacco cessation product that works.

Teenagers Smoke Too

Sure, they’ll say they’re doing it “for the children,” because e-cigarettes contain nicotine—a highly addictive chemical—but that is merely a red herring. 48 states already banned vape sales to minors prior to the FDA’s new rules. Furthermore, as much as nobody wants to admit it, taking vapes out of the hands of babes results in more of them smoking traditional cigarettes. In a study published last March, researchers at Cornell University found that teen smoking of traditional tobacco products—which on average contain much more nicotine than vape juice—went up by nearly 12 percent in states that instituted age limits on purchases of e-cigarettes.

If Rep. Price wants to take a big first step as Secretary of Health and Human Services to improve public health, he should listen to the current Director of FDA’s Center for Tobacco Products, Mitch Zeller, who declared that “If we could get all those people [who smoke] to completely switch all of their cigarettes to noncombustible cigarettes, it would be good for public health.” As researchers Konstantinos E. Farsalinos and Riccardo Polosa of the Onassis Cardiac Surgery Center put it, electronic cigarettes “represent a historical opportunity to save millions of lives and significantly reduce the burden of smoking-related diseases worldwide.” And accomplishing this laudable goal doesn’t even require government handouts—it merely demands the government agency get out of the way of the free market.